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The FDA issued a warning letter to Innova Medical Group in Pasadena, California for false and misleading labeling for its SARS-CoV-2 antigen rapid qualitative test, as well as marketing the test without FDA clearance and a slew of GMP observations at two facilities. Read More
The EU Medical Device Regulation (MDR), which went into effect on May 26, has caused some countries, including Switzerland, to lose direct access to the EU single market as they must update their mutual equivalency agreements in order to trade with the bloc. Read More
Canadian hospitals reported almost 3,500 medical device incidents to Health Canada in 2020, the agency said in a progress report on mandatory reporting requirements introduced as part of the agency’s Medical Device Action Plan. Read More
Australia’s Therapeutic Goods Administration is proposing to ease certain requirements in its regulatory framework for custom-made and 3D-printed devices that became effective in February. Read More
Although many diagnostics firms were hoping that the effective date of the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) would be further delayed, the EU Medical Device Coordination Group (MDCG) unveiled a joint implementation and preparedness plan for the IVDR indicating that the new requirements will go into effect as planned. Read More
Groups that will be impacted by the EU’s In Vitro Diagnostic Regulation (IVDR) are calling for urgent action to further delay its May 26, 2022 effective date and for a phased implementation. Read More
"We're excited to offer patients a method of relief that is nonaddictive and noninvasive," said Sean Edwards, the company’s executive chairman. Read More
The device uses a technique called hypofractionation, which has shown effectiveness in treating a variety of malignancies, including prostate, breast and lung cancers. Read More
The breakthrough designation applies to use of the device to treat squamous-cell carcinoma of the skin and oral cavity without curative standard of care. Read More